Phase III Study of Chemo-hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-naives Prostate Cancer Patients.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival rate
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.
PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation with vs without docetaxel.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
- Compare the PSA response rate in patients treated with these regimens.
- Compare the response rate in patients with measurable disease treated with these regimens.
- Compare the percentage of patients who undergo PSA normalization.
- Compare the quality of life of patients treated with these regimens.
- Compare the efficacy of these regimens in controlling bone pain in these patients.
- Compare the changes in chromogranin A levels in patients treated with these regimens.
- Compare the total cost of care of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients continue to receive LHRH-A therapy until disease progression.
干预措施: releasing hormone agonist therapy (Drug)
Arm II
Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: docetaxel (Drug)
Arm II
Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: releasing hormone agonist therapy (Drug)
结局指标
主要结局
2-year progression-free survival rate
次要结局
- Overall survival
- Time to treatment failure
- Toxicity as assessed by NCI CTCAE criteria
- PSA response rate (> 50% reduction from baseline)
- Disease response rate as assessed by RECIST criteria (in patients with measurable disease)
- PSA normalization (normal range 0-4 ng/mL)
- Quality of life
- Efficacy of treatment in controlling bone pain
- Changes in chromogranin A levels
- Cost analysis